[Product Review] AlaxoStent Review (6” FDA Approved)

[SleepyCPAP]

 

I have been using the 6” AlaxoStent for four days and I’m glad I spent the money! Five Stars!

I am a long-time CPAP user (11+ years), with recently emerging expiratory Palatal Prolapse.  No matter what machine (CPAP, APAP, VAuto BiLevel) there is no setting which would deal with Palatal Prolapse, the closing of my soft palate on exhale. Those Palatal Prolapses were expanding into apneas, oxygen desaturations, etc.  The AlaxoStent, inserted through my nose until it just shows at the back of my throat, keeps that soft palate from collapsing in my sleep.  It is FDA approved for Obstructive Sleep Apnea by itself, but I am using it along with my VAuto and Bleep mask so I have the combined stent-and-PAP therapy.

I put the stent in with the tube and rod that comes in the kit.  The stent drawn inside the tube first, then the tube is pushed through the middle sinus passage to where you want it in the throat, and when the tube (only) is withdrawn back out through the nose the stent expands in place behind the soft palate.  The end of the stent braid that sticks out of the nostril must be taped to the upper lip or cheek so that the stent does not inadvertently shift in the night.  I will attach an image from a study, showing the soft palate placement (other patients may need to stent lower, behind the tongue, shown in close up circle).  
   

In the four days of use I’ve experienced AHI’s of 0.3 (not quite placed right on my first night’s try), 0.0, 0.0 and 0.0 (all placed correctly).  No Palatal Prolapse waveforms are seen in my OSCAR breaths on those 0.0 nights, and very very few on the first night.  This, as I said above, leads me to five star rating and totally worth the price.  I’m thinking this was a better overall payback on investment compared to getting the VAuto after years of plain CPAP (and I love the VAuto).

I have also tried the AlexoStent by itself (no PAP mask) on a two hour nap in bed, where I was dozing in and out, and I wore my O2Ring.  The O2Ring showed only five brief desaturations (none 4% or more), and at no time had my SpO2 dropped below 93% (average 96%). My guess is these were RERAs or (brief Hypopneas at most), meaning the AlaxoStent was doing well on its own keeping me breathing (my sleep study was 33 AHI, for comparison).  Again, well worth the cost, and much easier to consider for naps when I don’t have the ability to mask up. Up to now I’ve refused to nap without my machine, so this definitely adds an option.

What I like: small travel case holds all I need. This protective case could fit in the outer pocket of my roll-on case in the over-seat bin on the airplane.  Except for the small part taped outside the nostril there are no masks, straps (or morning marks), or things to get in the way if I want to kiss my wife.  I could put this in and sleep on the plane, and nobody would know under my COVID mask.  I like that it targets the one area that is causing my sleep problems - the soft palate - without surgery.

What I’m learning gets better, but not so great the first couple days: Inserting the delivery tube through the middle sinus passage and then the quick bend down the throat took a couple day’s practice, and I realize I’m still learning to be better at it my fourth night of using it. Note: this was less of a difficulty than my first attempts at getting a leak-free mask fit with CPAP, but had some small discomfort for me the first couple tries.

Downside, but seems to be going away: My nose was dripping for a long time the first times I put it in (I started by putting it in 2 hours before sleep, so it was not dripping when I put my Bleep Dreamports on my nostrils just before sleep). That dripping period is already starting to be shorter, and less of an amount, and perhaps will go away as my body gets used to this object in there.  (No, I have not experienced any nosebleeds, saline spray is recommended if you have dry passages, I tried it once but I find I don’t need it.).

What is still a downside:  Takes a little time to put in correctly, must be done in front of a mirror (comparable to my Bleep mask) and since I use it with my PAP machine and mask it means more taping so as to have no (or low) pressure seepage around the part that comes out the nostril. Also takes a few minutes longer in the morning (compared to typical mask morning routine) to wash out the mucus on the stent, and do the rinse/disinfect, rinse/disinfect process before setting it out to dry.  
Also feels a little scratchy at the back of my throat when I swallow.  I don’t notice it when sleeping, but I do when I’m awake.

I’ll update this review as I get more use from the AlaxoStent.

Tips to readers:  There was a push for me to start with the short nasal stents, not the 6”.  I don’t have nasal issues, so that would have been worthless “practice”. (I’m glad I dove in straight to 6”). If you have nasal blockage it might be worth starting with their 2” or 3”, which I’m assuming you get to keep and use on one side after you graduate to the 6” stent on the other side.
Tip: despite the way it looks in the illustration, the 6” AlaxoStent does not expand in the sinuses, just the final 4 cm that reaches into the throat expands it’s shape.
Another tip: if you have trouble getting your own doctor to prescribe this, even though it is FDA approved, Alaxo has a company-referred doctor who can do a virtual appointment with you.  I had to go that route because my regular doctor was unfamiliar and didn’t want to prescribe, and I was having trouble finding an appointment with an ENT in my region.
Maybe a future issue: The disinfectant they supply (75ml spray bottle) is a substitute for the brand recommended in their literature, because of supply shortages. I don’t know how long this small bottle lasts, and don’t know what will be recommended when this finally runs out (I’m assuming I’ll use it up well before the 500-use rating of the stent).
Tip: there are YouTube videos showing people putting stents in.  The short ones don’t need taping, due to their shape, but this 6” version does - I don’t think they make that clear!  Also no video shows taking out the stent, maybe because you just slowly pull on it (in its expanded shape) and a bunch of mucus is on it that needs to be rinsed off immediately.  To me it feels like pulling a soft (fat) feather through the sinuses (not that I’ve done that, but that’s the closest I can imagine).

I will not post the link to AlaxoUSA or AlaxoCanada (or their EU site) since they sell the FDA-approved sleep apnea device directly and that might break forum rules.  Just do an internet search, it is likely the company will come up as the first hit.

[Sleeprider]

Really glad to see this review posted as this problem has come up several times among users on the forum. It's always been hard to point to first-hand experience with the AlaxoStent to help and demonstrate a potential for success. I want to link to your therapy thread so others can see what your untreated Oscar charts look like and your progress to using a stent. http://www.apneaboard.com/forums/Thread-...AlaxoStent

I notice on the Alaxo site that the stent costs $974 USD. Did you have insurance coverage for this, or did you cover the cost out-of-pocket? Have you discussed the use of the stent with your doctor?

[SleepyCPAP]

I notice on the Alaxo site that the stent costs $974 USD.  Did you have insurance coverage for this, or did you cover the cost out-of-pocket?  Have you discussed the use of the stent with your doctor?

Thanks for updating my treatment thread title - it might catch more eyes from folks who are looking.

Yes, I discussed with my primary care provider, and my sleep doctor.  Neither had heard of it before and were uncomfortable recommending it.  I will send them reports when I’ve had more time with the stent, maybe as I’m titrating PAP pressure downward.

I called my insurance company after purchase, as Alaxo had given me the proper insurance code.  I was fully prepared to pay for this out of pocket, without reimbursement.  It turns out my insurance won’t reimburse for the AlaxoStent, at least the first level of call-center representative asked me for the code and looked it up and said “no.”  I suppose I could fight it up the line to higher levels if it was worth it to me. But as I’ve said, I was prepared to pay for this no matter whether reimbursement was possible. And I’m unclear about whether I’d be approved after lots of effort, but still have to pay the full cost due to deductible limits not met.

[SleepyCPAP]

Here is an update now that I've had half a month with the 6" AlaxoStent (which I use in combination with my VAuto).

I just now looked over my stats for the first 15 days of this month (no AlaxoStent use, just VAuto), and compared to the last 15 days (with AlaxoStent combined with my VAuto). According to OSCAR, I had 315 OA's scored in the first 15 days, compared to 3 OA's since I started using the stent (also 15 days). It took me less than a half hour of the very first night of the month to get to 3 OA's (no stent), whereas it was a week to get there with the stent in place (and two of the three were on the first night when I didn't get the AlaxoStent placed quite right).

By the way, I have not had any OA's since Dec. 22 (which was still within that first week of stent use).

If I multiply how many OA's I'd get over the next 18 months (manufacturer's replacement recommendation), I'd guess the AlaxoStent will reduce my cumulative OA count by a whopping 11,232 (compared to not using the stent). YMMV.

Also, in terms of Time-in-Apnea, my OA's brought me a mere 1 minute 10 seconds of Time-in-Apnea over these 15 days of stent use, and this great result is true even though my VAuto pressure setting is now down 2cm (so far, and I'm still slowly reducing, with permission of my sleep doctor).

I'm also averaging a little more sleep per night now that I'm using the 6" AlaxoStent, according to OSCAR's overview charts.  Of course sleep is affected by many factors, but elimination of so many obstructions has got to be a major part of the mix.

I'm no longer having any nose dripping on insertion, so I don't have to put it in way before bed.  Putting it in is going more quickly and smoothly with experience too.  In the mornings the cleaning time is quicker (less mucus).

I've tried it with both the Bleep mask and the Swift FX and both work.

As I said above, I took a nap with just the stent, not PAP, and my O2Ring said my stats were in the same SpO2 range (lowest dip was 93%). I also did this for the first hour of bedtime once or twice, similar SpO2 with the O2Ring, as it allowed more snuggle time falling asleep with my wife and I not dealing with a mask between us. I would trust this AlaxoStent alone (but I still feel the combined therapy with VAuto is perfect for me).

No evidence of Palatal Prolapse breath waves since that first night, but I've occasionally seen some snores and sharp tips of the exhale curves sometimes which leads me to believe the stent is overcoming those continued persistent soft palate issues.  It's working!

It just keeps getting better.

- SleepyCPAP

[SleepyCPAP]

Quick Review Update on AlaxoStent, at 1-month’s use.

This stent is continuing to surpass my expectations. It not only got rid of the expiratory Palatal Prolapse, it seems it is also taking care of all my obstructive apneas as well. My slow pressure reduction on my PAP device is now less than half of the pressure compared to pre-AlaxoStent nights (currently EPAP 3, IPAP 6 cm in “S” mode). And I keep going lower (and am about to run out of lower settings on this machine).

I have had 0.0 AHI for more than a week straight, and the same 0.0 AHI on 20 of the 30 nights total. The average AHI for the month is 0.07 (because of some CA’s, and the very early days when I had three OA’s before I got used to replicating best placement of the stent each night).

My O2Ring confirms the efficacy - I’m usually in the 95%-99% range of SpO2 during each night, sometimes dipping into the 90%-94% range. Dipping below 90% is so rare now, I’ve seen it happen only a couple nights this past month, for a total monthly time below 90% calculated as a mere 24 seconds (to 89% a couple times and 88% one night for an instant).

My previous post mentioned my worrying about supply of the disinfectant spray. It is a rare (in US) German-made disinfectant (ProntoSan is the one they mention in the manual, but they substituted the similar ProntoLind in my box, with the same active ingredients). Alaxo has a care guide call me occasionally and check how I’m doing, and on the most recent call I’ve asked how to get a re-supply of the 75ml bottle (or refill), and so far they do not have an answer. I think I’m spraying too much.

I no longer have any mask leaks. In part this due to better skill at sealing around the tail of the stent that comes out the nostril, and in large part because the low pressures are not a problem for the seal.

- SleepyCPAP

[SleepyCPAP]

This is an update at three months, with the new information I got.

Still loving the therapy I get!  No side effects, and consistently good efficacy. So much less scary than surgical options I’d like to avoid.

FYI: The officially recommended disinfectant spray (Braun Prontosan) is still hard to find, and isn’t cheap.  I got a refill bottle online just before I ran out, but I think the online supplier is showing low stock now.  The AlaxoStent folks have suggested alternative substitutes should this supply run out, and are responsive to customer questions. The main thing they warned: don’t use peroxide cleaners!!!  I think they believe cleaners containing peroxide may eat the protective coating of the stent. 

Sleep Study: My doctor approved a sleep study to see how the 6” AlaxoStent does on its own.  The results show it brings my AHI down to 2.7 (mostly Hypopneas), and RDI down to 11.7.  Contrast this to the Severe OSA diagnosis of my original sleep study, which showed 33.8 AHI, and arousal index of 45.3.   The AlaxoStent works!

As I said above, I use the stent on its own for naps, and I have tried it by itself on some nights. I think someone who can’t deal with CPAP would love this option for every sleep time, or even travelers, campers and backpackers (no lugging batteries or CPAP!).

Since I am well adjusted to PAP machines, I don’t usually use the stent alone. And I can’t use my PAP machine alone, as it doesn’t address my soft palate collapse on exhale.  I still find my perfect results (0.0 AHI, night after night) are from combining use of the AlaxoStent and PAP therapy. The PAP machine (now at softer pressure!) gets rid of the last bits of AHI and RDI that the stent doesn’t address, my blood oxygen for the night is usually a point higher on average this way, and as I said above, I seem to sleep a little longer with the two combined.

- SleepyCPAP

[Sleeprider]

What do you expect the replacement interval for the Stent to be?

[SleepyCPAP]

SleepRider, 

The official replacement schedule for the AlaxoStent is 18 months.  

As to what my personal replacement choices will be, well… I do not wish to discourage people from safest practices, but I know from my own experience I don’t replace masks, humidifier tanks, hoses, or machines in the intervals suggested. I pay out-of-pocket and try to get the most out of what I get, without unnecessary waste (and I don’t do early turnover of insurance-paid items either).  I use sleep apnea supplies until I’m done with them.  I’ll update this thread in 15 months to let you know.

- SleepyCPAP

[yankees123]

Hi sleepycpap, just read about your adventures.  Would you mind looking at the posts I have placed today?  I would like your analysis.  
Thanks

[SleepyCPAP]

Quick update almost 9 months later:
I’m totally satisfied with the combined therapy I’m getting with the AlaxoStent and the VAuto (at it’s reduced pressure). The VAuto rarely deals with a random FL here and there, mostly staying at EPAP min (4cm).

Since March (when I last tweaked my current pressure settings) my average AHI has been 0.025. 85% of nights are 0.00 AHI, the rest are nights with an occasional small hypopnea or random CA, and the one highest AHI night was 0.274 (only two nights were at or above 0.2 AHI).

Sometimes I’ve just used the stent, such as a nap, or if I’m reading in bed and fall asleep before masking up.

I’ve had no nasal or throat issues from using the stent.

My sleep doctor calls this excellent results! Me too. Worth every penny.